Unleashing the full potential of digital outcome measures in clinical trials: eight questions that need attention.

ABSTRACT: The use of digital health technologies to measure outcomes in clinical trials opens new opportunities as well as methodological challenges. Digital outcome measures may provide more sensitive and higher-frequency measurements but pose vital statistical challenges around how such outcomes should be defined and validated and how trials incorporating digital outcome measures should be designed and analysed. This article presents eight methodological questions, exploring issues such as the length of measurement period, choice of summary statistic and definition and handling of missing data as well as the potential for new estimands and new analyses to leverage the time series data from digital devices. The impact of key issues highlighted by the eight questions on a primary analysis of a trial

SUBMITTER: Tackney MS 

PROVIDER: S-EPMC11438362 | biostudies-literature | 2024 Sep

REPOSITORIES: biostudies-literature